Syncvision System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Syncvision System |
Not applicable |
400-0100.10 |
Issue
If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system. This error will appear "insufficient data, distal segment is not co-registered" the risk of suboptimal patient treatment due to falsely elevated data on the initial trendline for the IFR/FFR co-registration would be greatest from inexperienced interventionalists.
Recall start date: Dec 10, 2021
Additional information
Details
Company: Philips Electronics Ltd.
1875 Buckhorn Gate, Mississauga, Ontario
Canada, L4W 5P1
Company: Volcano Corporation
3721 Valley Centre Drive, Suite 500, San Diego, California
United States, 92130
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